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Recruiting NCT05914545

A Study of FZ-AD004 in Patients With Advanced Solid Tumors

Phase I Interventional Advanced and Metastatic Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FZ-AD004.
Who it may be relevant to
Registry conditions: Advanced and Metastatic Solid Tumor. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD004 in Patients With Advanced Solid Tumors

Overview

This study is one single group of participants with advanced solid tumors. It is the first time the drug has been used in humans. There will be two parts including Dose Escalation and Dose Expansion to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of FZ-AD004.

Detailed description

This is a first-in-human (FIH), Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of FZ-AD004 in patients with advanced/metastatic solid tumors. FZ-AD004 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD) and dose-limiting toxicities（DLT）during cycle 1. In addition, the maximum-tolerated dose and recommended Phase II dose for FZ-AD004 will be determined.

Interventions

  • Drug FZ-AD004
    Dose Escalation：Subjects will receive an intravenous infusion of FZ-AD004 in a dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study. Dose Expansion：Subject will receive a single dose of FZ-AD004 at 1-2 dose level on Day1 of each cycles.

Primary outcome measures

  • The dose limiting toxicity ( DLT) [Time frame: 21 Days (first cycle)]
  • Maximum Tolerable Dose (MTD) [Time frame: 21 Days (first cycle)]
  • Adverse Events [Time frame: Screening up to study completion]
  • Objective Response Rate (ORR) according to RECIST 1.1 [Time frame: From subject randomization up to 60 months.]
Secondary outcome measures (8)
  • Progression free survival(PFS) according to RECIST 1.1 [Time frame: From subject randomization up to 60 months.]
  • Duration of Response(DOR) according to RECIST 1.1 [Time frame: From subject randomization up to 60 months]
  • Overall Survival (OS) according to RECIST 1.1 [Time frame: From subject randomization up to 60 months.]
  • Terminal elimination half-life (t1/2) of Total Antibody, Free DXd and FZ-AD004 [Time frame: Up to 17 weeks]
  • Maximum observed plasma concentration (Cmax) of Total Antibody, Free DXd and FZ-AD004 [Time frame: Up to 17 weeks]
  • Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity of Total Antibody, Free DXd and FZ-AD004 [Time frame: Up to 17 weeks]
  • Time to Cmax (Tmax) of Total Antibody, Free DXd and FZ-AD004 [Time frame: Up to 17 weeks]
  • Number of subjects who develop detectable anti-drug antibodies (ADAs) [Time frame: From subject randomization up to 60 months.]

Eligibility criteria

Inclusion criteria

  • Patients able to give written informed consent;
  • Age ≥ 18 and ≤ 75 years old, male or female;
  • Patients have histological or cytological diagnosis with advanced solid tumors.
  • Have measurable lesions defined in RECIST v. 1.1;
  • Expected survival ≥ 12 weeks;
  • Eastern Cancer Cooperative Group (ECOG) performance status 0-1;
  • Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment.

Exclusion criteria

  • Have had other malignant tumors in the past 5 years;
  • Have CNS (central nervous system) metastasis with clinical symptoms;
  • Had undergone major surgery or severe trauma within 4 weeks prior to the first dose;
  • Had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment;
  • Have history of psychotropic drug abuse, alcohol or drug abuse；
  • Women who are pregnant or lactating；
  • Other circumstances that is deemed not appropriate for the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Chest Hospital — Shanghai

Identifiers

NCT: NCT05914545 · F0040-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗